About this trial
The goal of this observational study is to evaluate the intravesical recurrence (IVR) rate after ureteroscopy (diagnostic or treatment) for upper tract urothelial carcinoma (UTUC) followed by an adjuvant single instillation of Mitomycin C (SI-MMC).
The main question it aims to answer are:
* What is the total and time to IVR after 2 years after ureteroscopy (diagnostic or treatment) for UTUC * How is the IVR compared with a historical cohort (no SI-MMC) * What is the time to IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy (RNU) * What is the additional value of a SI-MMC on time to IVR after RNU + adjuvant MMC in patients who were evaluated by ureteroscopy prior to RNU
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients suspect for having non-metastatic disease and planned for ureteroscopy (diagnostic or treatment) and adjuvant single instillation of Mitomycin C
Age ≥18 years
Written informed consent
Disqualifiers
History of histological proven urothelial carcinoma of the bladder, including carcinoma in situ
History of histological proven UTUC in the contralateral kidney
Concurrent bladder tumour found pre-operatively or per-operatively
Patients where it is not feasible to obtain histology by biopsies intra-operatively
Trial population
Patients suspect of having non-metastatic UTUC
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Time to and total number of Intravesical recurrences (IVR)
What is the time to and total number of IVR 2 years after ureteroscopy (diagnostic or treatment) with SI-MMC for UTUC
Time to and total number of IVR after endoscopic vs radical treatment
What is the time to and total number of IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy
Time to and total IVR after diagnostic ureteroscopy in patients who received final treatment by RNU
Is there an additional value of SI-MMC on total and time to IVR after RNU in patients who were evaluated by ureteroscopy prior to RNU. Outcome measurement (time to IVR and total IVR) will be compared to a historical cohort who did not receive Mitomycin C to evaluate the additional effect
Secondary outcomes
predictive factors for IVR
to evaluate possible predictive factors for IVR rate looking different variables by multivariate logistic regression; with the dependent variable IVR and independent variables: gender (male/ female), tumour size (\< 2cm/ \>2cm), tumour focality (unifocal/ multifocal), tumour invasiveness (invasive/ non-invasive), tumour location (ureter/ puelocaliceal), use of Urethral access sheath (yes/no), use of postoperative stent (yes/ no), timing of MMC administartion (\<24h/\>24h)
Sponsors and contacts
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